No Prescription Needed—FDA Gives Gland’s Vizag Plant a Clean Bill of Health

Image Source: Medical Dialogues

Gland Pharma Ltd (NSE: GLAND.NS) received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) at the company's JNPC facility in Visakhapatnam, Andhra Pradesh. The EIR is a confirmation of the satisfactory execution of a Pre-Approval Inspection (PAI) between February 19 and February 25, 2025, of the Sterile Active Pharmaceutical Ingredients (APIs) plant of the company.

1. Inspection Outcome

The US FDA also issued a Form 483 with three procedural observations that were not repeat items or data integrity-related.
Gland Pharma has assured to submit corrective and preventive actions (CAPA) within the specified timeline.
The EIR establishes the fact that the company's initial response is acceptable to the FDA and no further regulatory action is presently scheduled.

2. Strategic Importance

The JNPC plant is a significant contributor to Gland Pharma's injectable and sterile API pipeline for U.S. market.
It also supports the company's ability in accelerating the product filings and commercial launches from the plant.
It also highlights Gland Pharma's compliance track record, following an earlier same kind of EIR this year on its Dundigal unit near Hyderabad.

3. Market Implications

The EIR will help to increase investor confidence and will enable Gland Pharma's expansion strategy worldwide.
The company continues to focus on complex injectables, biosimilars, and penetration in regulated markets, particularly in the U.S. and EU.

Sources: Gland Pharma – Official US FDA EIR Disclosure, Business Standard, The Hindu